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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000012745
Receipt No. R000014848
Scientific Title Randomized controlled trial on the usefulness of ninjinyoeito (Kampo formula) for oxaliplatin-induced peripheral neuropathy and anemia (HOPE-2)
Date of disclosure of the study information 2014/01/06
Last modified on 2020/07/07

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Basic information
Public title Randomized controlled trial on the usefulness of ninjinyoeito (Kampo formula) for oxaliplatin-induced peripheral neuropathy and anemia (HOPE-2)
Acronym HOPE-2
Scientific Title Randomized controlled trial on the usefulness of ninjinyoeito (Kampo formula) for oxaliplatin-induced peripheral neuropathy and anemia (HOPE-2)
Scientific Title:Acronym HOPE-2
Region
Japan

Condition
Condition Colorectal cancers
Classification by specialty
Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine whether ninjinyoeito attenuates oxaliplatin-induced peripheral neuropathy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes peripheral neuropathy
Key secondary outcomes hemoglobin concentration
neutrophil count
platelet count

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administraion of Tsumura ninjinyoeito extracted granule (for ethical use)
Interventions/Control_2 Non-administraion of Tsumura ninjinyoeito extracted granule (for ethical use)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >=
Gender Male and Female
Key inclusion criteria 1. Pathologically-proven colorectal cancers
2. Pathologically-proven stage IIIa or IIIb
3. Curative A resected
4. No history of chemotherapy, immunotherapy, or radiotherapy for pain control
5. More than 2 weeks after operation
6. PS 0-1
7. No severe dysfunction in major organs
8. Oral intake is possible
Key exclusion criteria 1. Blood transfusion or G-CSF administration within 7 days
2. Pleural effusion, ascites, or pericardial effusion, necessary for drainage
3. double cancers
4. drug hypersensitivity
5. diabetic neuropathy
6. diabetes mellitus, necessary for insulin therapy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yoshiharu
Middle name
Last name Motoo
Organization Kanazawa Medical University
Division name Department of Medical Oncology
Zip code 920-0293
Address 1-1 Daigaku, Uchinada, Ishikawa 9200293, Japan
TEL 076-286-2211
Email motoo@kanazawa-med.ac.jp

Public contact
Name of contact person
1st name Yoshiharu
Middle name
Last name Motoo
Organization Kanazawa Medical University
Division name Department of Medical Oncology
Zip code 920-0293
Address 1-1 Daigaku, Uchinada, Ishikawa 9200293, japan
TEL 076-286-2211
Homepage URL
Email motoo@kanazawa-med.ac.jp

Sponsor
Institute Kanazawa Medical University
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Clinical Research Center, Kanazawa Medical University Hospital
Address 1-1 Daigaku, Uchinada, Ishikawa 920-0293, Japan
Tel 076-286-2211
Email tiken@kanazawa-med.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 金沢医科大学病院(石川県)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 06 Day

Related information
URL releasing protocol https://pubmed.ncbi.nlm.nih.gov/32232692/
Publication of results Published

Result
URL related to results and publications https://pubmed.ncbi.nlm.nih.gov/32232692/
Number of participants that the trial has enrolled 52
Results
Ninjin7yoeito significantly ameliorated the grade of oxaliplatin-induced cumulative peripheral neuropathy.
Results date posted
2020 Year 07 Month 07 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with colorectal cancer, receiving 8 cycles of XELOX regimen as postoperative adjuvant chemotherapy
Participant flow
Randomly assigned to either ninjin'yoeito group or control group
Adverse events
A case of pseudoaldosteronism possibly caused by ninjin'yoeito
Outcome measures
Grade of cumulative peripheral neuropathy
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2013 Year 12 Month 19 Day
Date of IRB
2013 Year 12 Month 25 Day
Anticipated trial start date
2014 Year 01 Month 06 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
2017 Year 11 Month 30 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 01 Month 02 Day
Last modified on
2020 Year 07 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014848

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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